New Policy - Coverage Criteria Established for Irinotecan Liposomal (Onivyde)

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1 May 2017 In This Issue Quantity Limits for Breast Prosthesis and Mastectomy Bras... 5 Revised Criteria for Stereotactic Body Radiation Therapy... 6 Contents... 7 Policy New Policy - Coverage Criteria Established for Irinotecan Liposomal (Onivyde) Highmark Delaware has established coverage criteria for Irinotecan Liposomal (Onivyde ). Irinotecan Liposomal (Onivyde ) in combination with fluorouracil and leucovorin, may be medically necessary for the treatment of patients with metastatic adenocarcinoma of the pancreas after disease progression following gemcitabine-based therapy. This applies to both professional provider and facility claims. The effective date of the new policy is July 31, Please refer to Medical Policy I-161, Irinotecan Liposomal (Onivyde ) for coverage criteria and additional information. Highmark Delaware is an independent licensee of the Blue Cross and Blue Shield Association. NaviNet is a registered trademark of NaviNet, Inc., which is an independent company that provides a secure, web-based portal between providers and health insurance companies.

2 Coverage Criteria Established for Olaratumab (Lartruvo) Highmark Delaware has established new clinical criteria for Olaratumab (Lartruvo ) based on the FDA approved indications and the National Comprehensive Cancer Network (NCCN). This new criteria will apply to both professional provider and facility claims. The effective date is July 31, Please refer to Medical Policy I-162, Olaratumab (Lartruvo ) for additional information. Coverage Criteria Established for Parathyroid Hormone (Natpara) Highmark Delaware has established clinical criteria for Parathyroid Hormone (Natpara ) as an adjunct to calcium and vitamin D to treat individuals who meet all of the following: a diagnosis of hypocalcemia secondary to hypoparathyroidism; and hypocalcemia is uncontrolled with active vitamin D and calcium supplementation; and sufficient 25-hydroxyvitamin D stores (levels between 20 and 30 ng/ ml [50-75 nmol/l]); and serum calcium levels greater than or equal to 7.5 mg/dl; and is prescribed by or in consultation with an endocrinologist. This new criteria will apply to both professional provider and facility claims. The effective date is July 31, Please refer to Medical Policy I-164, Parathyroid Hormone (Natpara ) for additional information. 2

3 Coverage Criteria Established for Ocrelizumab (Ocrevus) Highmark Delaware has established clinical criteria for Ocrelizumab (Ocrevus ) for the treatment of relapsing forms of multiple sclerosis (MS) when the following conditions are met: patient is an adult 18 to 55 years of age with a diagnosis of relapsing forms of multiple sclerosis as defined by an MRI of the brain showing abnormalities consistent with MS and at least one relapse in the previous year or at least 2 relapses within the previous two years; and has an Expanded Disability Status Scale (EDSS) score of 0 to 5.5; and does not have an active Hepatitis B virus infection; and has not had a life-threatening infusion reaction to ocrelizumab. For primary progressive MS, ocrelizumab may be considered medically necessary when the following are met: patient is an adult 18 to 55 years of age with a diagnosis of primary progressive multiple sclerosis (PPMS) based on the McDonald criteria; and has an EDSS score of 3 to 6.5; and has an EDSS pyramidal functional system score (FFS) of 2 or greater; and does not have an active Hepatitis B virus infection; and has not had a life-threatening infusion reaction to ocrelizumab. This new criteria will apply to both professional provider and facility claims. The effective date is July 31, Please refer to Medical Policy I-171, Ocrelizumab (Ocrevus ) for additional information. Criteria Changes for Obinutuzumab (GAZYVA) Highmark Delaware has established new clinical criteria for Medical Policy I-137. This new criteria will apply to both professional provider and facility claims. The effective date is July 31, Obinutuzumab may be considered medically necessary: In combination with bendamustine followed by obinutuzumab monotherapy, for the treatment of patients with follicular lymphoma who relapsed after or are refractory to a rituximab-containing regimen; or As first line treatment of chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) when used in combination WITH chlorambuci. 3

4 Coverage Criteria Expanded for PD-1 Blocking Antibodies Highmark Delaware has established additional indications for Medical Policy I-120. This new revised criteria will apply to both professional provider and facility claims. The effective date is July 31, Hodgkin Lymphoma (classical Hodgkin Lymphoma) T Pembrolizumab is indicated for the treatment of adult and pediatric patients with: o Refractory classical Hodgkin Lymphoma (chl); or o Who have relapsed after three or more prior lines of therapy. Please refer to Medical Policy I-120, Oncologic Indications for PD-1 Blocking Antibodies for additional information. Criteria Changes for Treatment of Twin-Twin Transfusion Syndrome (TTS) with Amnioreduction and/or Fetoscopic Laser Therapy Highmark Delaware has established new clinical criteria for Medical Policy U-8. This new criteria will apply to both professional provider and facility claims. The effective date is July 31, Place of Service: Inpatient/Outpatient Amnioreduction may be considered medically necessary for TTS when ALL of the following criteria are met: After 26 weeks of gestation; and There is evidence of abnormal blood flow documented by Doppler studies in one or both fetuses; and There is evidence of polyhydramnios in the recipient fetus; and The donor fetus is oligohydramniotic. Fetoscopic laser therapy may be considered medically necessary for TTS when ALL of the following criteria are met: Fetal gestational age of less than 26 weeks; and There is evidence of polyhydramnios (excessive amniotic fluid) in the recipient fetus; and The donor fetus is oligohydramniotic (reduced amniotic fluid); and Evidence of abnormal blood flow documented by Doppler studies in one or both fetuses. 4

5 Exondys 51 Considered Experimental/Investigational Effective July 31, 2017, Highmark Delaware will consider Exondys 51 experimental/ investigational. For additional information see Medical Policy I-152, Exondys 51. REMINDER: Molecular and Genomic Testing Highmark Delaware is providing a reminder to all providers. As previously announced in the May 26, 2017 Special Bulletin, the molecular and genomic testing medical policies and requirements will be updated and take effect July 31, This applies to both professional provider and facility claims. At that time, policies can be accessed from the medical policy homepage. Quantity Limits for Breast Prosthesis and Mastectomy Bras Highmark Delaware has established new clinical criteria for Medical Policy S-129, Mastectomy and Reconstructive Surgery. This new criteria will apply to both professional provider and facility claims. The effective date is July 31, Up to four bras will be covered the first twelve months after mastectomy. Up to two bras will be covered annually thirteen months after mastectomy. Allowable frequency of breast prosthesis will be based on the type of prosthetic being requested. 5

6 Updated Criteria for Electroconvulsive Therapy Highmark Delaware has established new clinical criteria for Medical Policy G-26, Electroconvulsive Therapy. This new criteria will apply to both professional provider and facility claims. The effective date is July 31, Neuroleptic malignant syndrome is being added with criteria. Criteria will be further defined for Catatonia, Mania, depressive disorders, and schizoaffective disorders. Revised Criteria for Stereotactic Body Radiation Therapy Effective July 31, 2017, Stereotactic Body Radiation Therapy clinical criteria has been revised. The following clinical criteria have been revised. Stereotactic body radiation therapy (SBRT) may be considered medically necessary for non-small cell lung cancer when ALL of the following are met: Primary T1 or T2 non-small cell lung cancer (Single lesion not greater than 5 cm); and No nodal or distant disease; and Are not candidates for surgical resection. Stereotactic body radiation therapy (SBRT) may be considered medically necessary for localized prostate cancer when ALL of the following are met: Low grade prostate cancer defined by a Gleason score equal to 6 and prostatespecific antigen (PSA) less than 10 ng/ml; and Minimal disease defined as less than four cores positive; and No evidence of extraprostatic disease. Please refer to Medical Policy R-14 for additional information. 6

7 Comments on these new medical policies? We want to know what you think about our new medical policy changes. Send us an with any questions or comments that you may have on the new medical policies in this edition of Medical Policy Update. Write to us at New Policy - Coverage Criteria Established for Irinotecan Liposomal (Onivyde)... 1 Coverage Criteria Established for Olaratumab (Lartruvo)... 2 Coverage Criteria Established for Parathyroid Hormone (Natpara)... 2 Coverage Criteria Established for Ocrelizumab (Ocrevus)... 3 Criteria Changes for Obinutuzumab (GAZYVA)... 3 Coverage Criteria Expanded for PD-1 Blocking Antibodies... 4 Criteria Changes for Treatment of Twin-Twin Transfusion Syndrome (TTS) with Amnioreduction and/or Fetoscopic Laser Therapy... 4 Exondys 51 Considered Experimental/Investigational... 5 REMINDER: Molecular and Genomic Testing... 5 Quantity Limits for Breast Prosthesis and Mastectomy Bras... 5 Updated Criteria for Electroconvulsive Therapy... 6 Revised Criteria for Stereotactic Body Radiation Therapy... 6 Comments on these new medical policies?... 7 Contents... 7 Save yourself valuable time with e-subscribe! Sign up today and you ll begin receiving notifications with a direct link to the latest issue of Medical Policy Update. About this newsletter Medical Policy Update is the monthly newsletter for most health care professionals (and office staff) and facilities who participate in our networks and submit claims to Highmark using the 837P HIPAA transaction or the CMS 1500 form, or the 837I HIPAA transaction. Medical Policy Update focuses only on medical policy and claims administration updates, including coding guidelines and procedure code revisions, and is the sole source for this information. For all other news, information and updates, be sure to read Provider News, available on the Provider Resource Center at Inquiries about Eligibility, Benefits, Claims Status or Authorizations For inquiries about eligibility, benefits, claim status or authorizations, Highmark Delaware encourages providers to use the electronic resources available to them - Navinet and the applicable HIPAA transactions prior to placing a telephone call to the Provider Service Center at Acknowledgement The five-digit numeric codes that appear in Medical Policy Update were obtained from the Current Procedural Terminology (CPT), as contained in CPT- 2017, Copyright 2016, by the American Medical Association. Medical Policy Update includes CPT descriptive terms and numeric procedure codes and modifiers that are copyrighted by the American Medical Association. These procedure codes and modifiers are used for reporting medical services and procedures. 7